NCT00239642

Safety and Efficacy of Iron Sucrose in Children

Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Detailed description

Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Conditions

• Anemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Venofer (iron sucrose injection)	0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
DRUG	Venofer (iron sucrose injection)	1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
DRUG	Venofer (iron sucrose injection)	2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-01-01
• Completion: 2010-04-01
• First posted: 2005-10-17
• Last updated: 2021-11-17
• Results posted: 2012-01-10

Locations

1 site across 1 country: United States